Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study

To determine the quality of life following the radical excision of recto-vaginal endometriosis.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis Rectovaginal Septum
• Intervention / Treatment: Procedure: Surgery for severe endometriosis

Detailed Description

Patients undergoing surgery for severe endometriosis with bowel involvement were asked to complete pre-operative and post operative questionnaires at 2, 6 and 12 months, then 5, 10, 15, 20 and 25 years post operatively.

Quality of life measured using the EHP-30 and EQ-5D questionnaires. Bowel symptoms were measured using GIQLI. Dysmenorrhoea, dyspareunia, dyschezia and chronic pain were measured using a visual analogue scale.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Andrew Kent, TD MD FRCOG; Email: kenta@doctors.org.uk

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
      • Recruiting
      • Royal Surrey County Hospital NHS Trust
      • Contact: Andrew Kent, TD MD FRCOG; Email: kenta@doctors.org.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who underwent surgery for endometriosis with bowel involvement.

Description

Inclusion Criteria:

• All women undergoing planned surgery for severe endometriosis with bowel involvement.

Exclusion Criteria:

• Patients who declined to complete questionnaires for whatever reason and/or have their anonymous data analysed.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery for severe endometriosis; Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement	Procedure: Surgery for severe endometriosis; Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires.	Recruitment is continuous	1 year post operative
Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).	Recruitment is continuous	1 year post operative
Dysmenorrhoea measured using a visual analogue scale (VAS).	Recruitment is continuous	1 year post operative
Dyspareunia measured using a visual analogue scale (VAS).	Recruitment is continuous	1 year post operative
Dyschezia measured using a visual analogue scale (VAS).	Recruitment is continuous	1 year post operative
Chronic pain measured using a visual analogue scale (VAS).	Recruitment is continuous	1 year post operative

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life measured using the EHP-30 and EQ-5D questionnaires.	2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Bowel symptoms were measured using GIQLI.	2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Dysmenorrhoea measured using a visual analogue scale.	2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Dyspareunia measured using a visual analogue scale.	2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Dyschezia measured using a visual analogue scale.	2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Chronic pain measured using a visual analogue scale.	2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

Collaborators and Investigators

• Sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Andrew Kent, TD MD FRCOG, Royal Surrey County Hospital/Nuffield Health Guildford Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): January 1, 2040

Study Registration Dates

• First Submitted: June 6, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (ESTIMATE): June 15, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 15DEV0009